MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

METICULY Patient-specific titanium maxillofacial mesh implant

FDA 510(k)

FDA Class 2 ·Dental

Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR

ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72

FDA 510(k)

FDA Class 2 ·Hematology

MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU

FDA 510(k)

FDA Class 2 ·General Hospital

RINSE MACHINE KR-4 KIDNEY RINSE-4

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Pantheon Proximal Femur Reconstruction (PFR) System

FDA 510(k)

FDA Class 2 ·Orthopedic

Cystatin C

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241

FDA 510(k)

FDA Class 2 ·General Hospital

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR

AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LASER MECHANISMS LASER SCANNING SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Mri Disposable Kit

FDA classification

FDA Class 2 ·Mri Disposable Kit

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·GELFLEX(R) (DIMEFILCON A) CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SILSOFT (ELASTOFILCON A ) CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SILSOFT (ELASTOFILCON A ) CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SILSOFT (ELASTOFILCON A ) CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SILSOFT (ELASTOFILCON A ) CONTACT LENS